Gastrointestinal Motility and Sleep Disturbances in Patients With Quiescent Crohn's Disease
In this study we would like to clarify the effect of long lasting Crohn's Disease on motility of the gastrointestinal system in patient and the effect regarding sleep disturbances. This will be done with a newly developed 3D-Motility-and-Transit-detector (Motilis Medica, Schweiz) and the well known polysomnographic equipment. Our hypothesises are: Patients with ileocoecal and/or colonic CD in remission and gastrointestinal symptoms have abnormal colonic transit (primary endpoint). 1. Patients with ileocoecal and/or colonic CD in remission and gastrointestinal symptoms have abnormal gastric emptying and small intestinal transit (secondary endpoints). 2. Total and segmental transit times found in patients with CD will be compared with corresponding transit times in healthy volunteers found in a previous study. 3. Patients with ileocoecal and/or colonic CD in remission have abnormal sleep patterns. 4. Nocturnal basic colonic activity, have changed in patients with ileocoecal and/or colonic CD in remission and sleep disturbances.
NCT02245594 — Crohn's Disease
Status: Not yet recruiting
http://inclinicaltrials.com/crohn-s-disease/NCT02245594/
The purpose of this study is to prospectively evaluate a scoring system to predict a mild course of disease in patients newly diagnosed with Crohn's disease.
NCT02193048 — Crohn's Disease
Status: Completed
http://inclinicaltrials.com/crohn-s-disease/NCT02193048/
A Phase 1 Study of Autologous Mesenchymal Stromal Cell Coated Fistula Plug in Patients With Fistulizing Crohn's Disease.
The investigators propose to study the safety of autologous mesenchymal stromal cell transfer using a biomatrix (the Gore® Bio-A®; Fistula Plug) in a Phase I study using a single dose of 20 million cells. Twenty adult patients (age 18 years or older) with refractory, complicated perianal fistulizing Crohn's disease will be enrolled. Subjects will undergo standard adjuvant therapy including drainage of infection and placement of a draining seton with continuation of pre-existing anti-Crohn's therapy. Six weeks post placement of the draining seton, the seton will be replaced with the MSC loaded Gore® Bio-A® fistula plug as per current clinical practice. The subjects will be subsequently followed for fistula response and closure for 24 months. This is an autologous product derived from the patient and used only for the same patient.
NCT01915927 — Perianal Crohn's Disease
Status: Completed
http://inclinicaltrials.com/perianal-crohn-s-disease/NCT01915927/
Evaluation of the PillCam® Platform With the PillCam Crohn's Disease Capsule in Visualization of Lesions in the Small Bowel and Colon That May Indicate Crohn's Disease
This is a prospective, multi-center (up to 6 sites) study which aims to To establish the effectiveness of the PillCam Platform with the PillCam Crohn's capsule as demonstrated by visualizing the small bowel and colon in patients with active symptoms associated with Crohn's disease (CD).
NCT01631435 — Crohn's Disease
Status: Completed
http://inclinicaltrials.com/crohn-s-disease/NCT01631435/
Humira® for Subcutaneous Injection Protocol for Special Investigation (Long-term Treatment for Crohn's Disease Patients)
This study of Humira will be conducted to obtain information on the safety (especially profile of malignant tumors and serious infections) and effectiveness in patients with Crohn's disease who are receiving Humira for a long period of time.
NCT01464333 — Crohn's Disease
Status: Completed
http://inclinicaltrials.com/crohn-s-disease/NCT01464333/
The Effect of Vitamin K Supplementation on Bone Health Indices in Adult Crohn's Disease
To assess the impact of a 12 month vitamin K supplementation intervention on bone health in adult Crohn's disease patients
NCT01235325 — Crohn's Disease
Status: Completed
http://inclinicaltrials.com/crohn-s-disease/NCT01235325/
Treatment of Fistulous Crohn's Disease by Implant of Autologous Mesenchymal Stem Cells Derived From Adipose Tissue
Primary outcome measure: Evaluation of viability, security and tolerance of the adipose-derived mesenchymal stem cells implant (ASCs) in fistulizing Crohn's disease patients, collecting the reactions and adverse events occurred during the study. Secondary outcome measures: 1. Evaluating the Adipose-derived mesenchymal stem cells therapeutic effect, in particular: - Fistulas healing efficiency - Changes in quality of life in patients treated - Changes of systemic Crohn's disease after implant - Relapse rate monitored among patients who achieved Adipose-derived mesenchymal Stem Cells treatment success. 2. Achieving the biological characterization of the cell product used and its correlation with the therapeutic effect measured with: - Phenotype study - Suppressor capacity study. - Citoquines production analysis
NCT01157650 — Crohn Disease
Status: Completed
http://inclinicaltrials.com/crohn-disease/NCT01157650/
MultiCTR Randomized Double-Blind Double-Dummy Study to Evaluate Clinical Efficacy/Safety of DR 6MP for Targeted Ileal Delivery vs Purinethol in Patients w/Moderately Active Crohn's Disease
The study is designed to evaluate the clinical efficacy and safety of daily treatment for 12 weeks of oral administration of a delayed release, locally delivered 6MP (mercaptopurine) drug (80 mg), as compared to standard Purinethol (at a dose of 1-1.5 mg/kg/body weight), in alleviating the clinical, immunological and mucosal signs and symptoms of moderately active Crohn's Disease
NCT01094613 — Crohn's Disease
Status: Terminated
http://inclinicaltrials.com/crohn-s-disease/NCT01094613/
A Cross Sectional Study To Determine The Relationship Between Serum Infliximab Concentration And Efficacy In Patients With Luminal Crohn's Disease
To assess the relationship between the change in Crohn's Disease Activity Index (CDAI) scores and trough serum infliximab concentration in subjects who are scheduled to receive infliximab infusions at an interval of 8 weeks.
NCT00676988 — Crohn's Disease
Status: Completed
http://inclinicaltrials.com/crohn-s-disease/NCT00676988/
Capsule Endoscopy Crohn's Disease Activity Index - Validation Multi Center Study
The Study 1. Prospective trial of the Niv score validating score against known activity indices - see addendum A for Niv score 2. Known Crohn's disease patients undergoing capsule endoscopy are identified - see addendum B for inclusion/exclusion criteria 3. Prior to capsule exam, temperature is taken, height and weight measured, bloods are drawn for albumin, ESR, HCT, CRP 4. Prior to capsule exam, symptom/exam questionnaire is completed - see addendum C for questionnaire 5. Capsule exam is performed 6. CD of de-identified is made at the study site. 7. Landmarks are confirmed and the small bowel transit time is divided into 2 and labeled on thumbnails 8. CDs are copied 9. CDs of study patients are provided to blinded readers
NCT00596700 — Crohn's Disease
Status: Completed
http://inclinicaltrials.com/crohn-s-disease/NCT00596700/